The first study evaluated the time to progression in newly-diagnosed multiple myeloma. The study compared the efficacy and safety of thalidomide plus dexamethasone compared to placebo plus dexamethasone.
Data from this study suggest that treatment with thalidomide and dexamethasone is superior to placebo plus dexamethasone, with a significantly longer time to progression, with significantly higher response rates. These data will support the marketing authorization application for thalidomide in the treatment of first-line multiple myeloma that Pharmion intends to file in Europe during the first quarter of 2007.
The second study examined the effect of the addition of thalidomide to maintenance therapy on progression-free survival and overall survival in myeloma patients following autologous stem cell transplant.
At six weeks following autologous stem cell transplant, patients were evaluated and those with no evidence of disease progression were randomized to maintenance alternate day prednisolone, with or without thalidomide.
Pharmion said that these data suggest that the addition of low-dose thalidomide to an alternate-day prednisolone maintenance regimen is an effective and tolerable therapeutic approach that prolongs the duration of disease response following stem cell transplant for multiple myeloma.